| CTRI Number |
CTRI/2023/09/057548 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
31/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Measurement of Carotid artery parameters in patients to look for response to fluid using ultrasound. |
|
Scientific Title of Study
|
Ultrasound guided measurement of Corrected Carotid Flow Time as a guide for fluid administration in spontaneously breathing patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheyna Williams |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi, 110029, India
South
DELHI
110029
India |
| Phone |
7837143218 |
| Fax |
|
| Email |
williamssheynaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kapil Gupta |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care,Ground floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi, 110029, India
South
DELHI
110029
India |
| Phone |
9811859019 |
| Fax |
|
| Email |
kapgup11@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka H Chhabra |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi, 110029, India
South
DELHI
110029
India |
| Phone |
9625154535 |
| Fax |
|
| Email |
priyankahsinghani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care,Ground floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi, 110029, India |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi, 110029, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sheyna Williams |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029
South
DELHI |
7837143218
williamssheynaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Passive leg raise maneuver |
Patient will be put in a 45degree semi-recumbent position followed by 45degree elevation of foot end. Parameters will be recorded before and after performing passive leg raise maneuver. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Class 1 to 3 |
|
| ExclusionCriteria |
| Details |
Patients with:
1. Knwon Carotid artery stenosis
2. History of cardiac dysfunction
3. History of pulmonary hypertension
4. History of peripheral vascular disease
5. Morbid obesity ( BMI >40kg/m2) |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasound assessment of the change in corrected carotid flow time (FTc) induced by passive leg raise (PLR) maneuver to be used as a predictor of fluid responsiveness in spontaneously breathing patients. |
Measured before PLR maneuver & 120seconds after PLR maneuver. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ultrasound assessment of the change in carotid artery blood flow peak velocity variability with different phases of breathing & carotid artery diameter induced by passive leg raise (PLR) maneuver to be used as a predictor of fluid responsiveness in spontaneously breathing patients. |
Measured before PLR maneuver & 120seconds after PLR maneuver. |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective interventional study to assess doppler ultrasound derived parameters like- corrected Carotid Flow Time, Carotid artery blood flow peak velocity, Carotid artery diameter as reliable predictors of fluid responsiveness in spontaneously breathing patients after passive leg raising (PLR) maneuver. |